MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, US CONFIGURATION; CATHETER, ELECTRODE RECORDING

Model Number D138402

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/29/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an unknown ngen rf generator.The patient experienced a skin burn that required wound debridement.It was reported that in a follow-up appointment after the initial procedure, it was noticed that there was a "lower blank burn on the patient's back".The nurse practitioner told the bwi representative that they believe that due to the location of the burn on the patient's back as well as the previous case being an afib case, they believe the two are correlated and that burn may be from the grounding patch.As far as they are aware the patient is stable and no medical intervention has been provided.They are yet to receive a statement from the physician as to what they believe the cause of the injury is.They stated that a q-dot micro catheter, a lasso 10-pole catheter, a soundstar 10f sms catheter, and a duo decapolar catheter were used in the case.None of the catheters are available for return.Additional information- no errors displayed on ngen.Physician¿s opinion on the cause of this adverse event was bwi product malfunction.It was confirmed that it was a 3rd degree burn.Intervention provided was hyperbaric chamber therapy; wound care.Indifferent electrode suspected; only 1 indifferent electrode patch suspected to have been connected for the case; covidien valleylab, rem polyhesive adult patient return electrode, serial/lot/batch unknown.The patient contact area and the indifferent electrode was properly prepared per the indifferent electrode instructions for use.The indifferent electrode placed on the patient¿s lower flank.It was positioned at a location on the back as close to the heart as possible.The entire surface area of the grounding pad was in complete contact with the patient¿s back.There was no air pockets present between the skin and the indifferent electrode.Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode and the indifferent electrode was moist.The indifferent was not used with the stockert generator.Generator settings was ngen generator; only 1 indifferent electrode thought to be connected; impedance ~120ohms; power 50w; total ablation time ~40min; 60seconds per ablation session maximum, unknown minimum time.Additional information- during this case were performed 51 rf ablations.All 51 ablations were done with qdot catheter in q mode high power mode with 50w power target and 50 degc temperature target.The initial impedance range was: 104 ¿ 173 ohm, with 117 ohm in the average.During all 51 ablations only one ie was connected to the bottom bp slot.During all 51 ablations (from the start to end of the case) the rf current distribution between the two halves of the ie was asymmetric.During the case only one split ie was connected to the bottom bp slot and partially touched the patient¿s skin.Note: a decrease in the area of the conductive surface of the ie below the norm can lead to a burn of the patient's skin.This is the first and only occurrence of burn reported.The event day was on 3/29/2023.Ngen generator information; ref# (b)(4); sn# (b)(4).No service needed.Additional information: medical records and photos were provided and were reviewed by clinician.The following is clinician summary: (b)(6) 2023 (procedure day) patient received a cardiac ablation procedure that included vascular access in both right and left groins and the right neck.Ablation was completed and required external cardioversion to achieve sinus rhythm.Esophageal monitoring was performed.Procedure was completed and marked that patient tolerated the procedure well and transferred in stable condition.No complications are noted for the procedure.Pacu (post anesthesia care unit) assessment was performed post procedure and the assessor noted a quarter size skin tear on the posterior right back and noted due to removal of pacer pads and treated with dressing and medication.Patient was then later discharged.The wound had progressed and required further assessment and treatment.On (b)(6) 2023: wound debridement was provided.Documentation provides the etiology was unknown by the wound debridement hcp (health care provider) and notes the wound appears as a second degree burn.Patient exhibited no signs or symptoms of infection such as fevers, chills or sweats.A debridement was performed as patient could tolerate and a plan of cleansing with soap and water, application of collagenase and mupirocin 50/50, periwound skin care with zinc oxide application, cover with nonadherent pad and change daily.Medication was prescribed at debridement procedure of an antibiotic as a precautionary if the wound got infected.No significant occurrences during wound debridement.The photos that were submitted confirm the report of skin breakage and a noted progression with a photo from day to a photo approximately 20 days later.Med hx: atrial fibrillation, hypertension, hypothyroidism, cardiac ablation, cardioversion, hysterectomy, tonsillectomy, breast reduction, eye surgeries this event is being reported for the additional unplanned surgery and third-degree burn.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

Manufacturer Narrative

Note: per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.However, the catheter used in this case, is not fda approved, therefore no pma details are available.Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no manufacturer record evaluation could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially ¿unk_ngen rf generator¿ product information was provided; however, on 14-jun-2023 the serial # of (b)(6) was provided.On 15-jun-2023 that serial # was corrected to (b)(6).Therefore, updated the following fields: d1.Brand name.D4.Serial.D4.Catalog.D4.Unique identifier( udi).H4.Device manufacture date.The product investigation was completed on 28-jun-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an ngen rf generator, us configuration.The patient experienced a skin burn that required wound debridement.The adverse event was investigated and the root cause was determined to be an indifferent electrode issue, not a generator issue.No malfunction was detected.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: NGEN RF GENERATOR, US CONFIGURATION
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16989687
• MDR Text Key: 315816959
• Report Number: 2029046-2023-01130
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835018080
• UDI-Public: 10846835018080
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D138402
• Device Catalogue Number: D138402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 7FR DEF LASSONAV SH,12P,20MM,D; DEF 7F,20P,DOME,DUO-DECAPOLAR; SOUNDSTAR ECO SMS 10F CATHETER; UNK_NGEN RF GENERATOR; UNK_QDOT MICRO
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female